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Treatment of Recurrent Bladder Cancer With Dendritic Cells

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
Belarus
Study Type
Interventional
Intervention
Dendritic cells
Standard treatment according to the Clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder Cancer, Dendritic cells

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed diagnosis of pTa bladder cancer;
  • Patient who require repetitive transurethral resection;
  • Expression of muc-1/wt-1 by the tumor;
  • EGOC 0-3;

Exclusion Criteria:

  • any medical condition which can be associated with the high risk for the patient;
  • pregnancy/lactation;
  • chronic infections, including hepatitis B/C, tuberculosis, HIV

Sites / Locations

  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dendritic cells

Control

Arm Description

Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells

Patients with the recurrent bladder cancer receiving standard treatment

Outcomes

Primary Outcome Measures

Efficacy evaluation
1 year relapse free survival

Secondary Outcome Measures

Full Information

First Posted
December 1, 2019
Last Updated
January 20, 2021
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04184232
Brief Title
Treatment of Recurrent Bladder Cancer With Dendritic Cells
Official Title
Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment of recurrent bladder cancer with dendritic cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder Cancer, Dendritic cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dendritic cells
Arm Type
Experimental
Arm Description
Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients with the recurrent bladder cancer receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
Dendritic cells
Intervention Description
Autologous dendritic cells primed with muc-1/wt-1 peptides
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the Clinical protocols
Intervention Description
Standard treatment of bladder cancer according to the Clinical protocols
Primary Outcome Measure Information:
Title
Efficacy evaluation
Description
1 year relapse free survival
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of pTa bladder cancer; Patient who require repetitive transurethral resection; Expression of muc-1/wt-1 by the tumor; EGOC 0-3; Exclusion Criteria: any medical condition which can be associated with the high risk for the patient; pregnancy/lactation; chronic infections, including hepatitis B/C, tuberculosis, HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Hancharou, Dr
Organizational Affiliation
Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexander V Prokharau, Dr
Organizational Affiliation
Head of the chair, Belarusian State Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Recurrent Bladder Cancer With Dendritic Cells

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